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Process Engineer

4 months ago

New Richmond, United States Tailored Management Full time

Process Engineer III

Job Location: New Richmond, WI

Executive Summary:

We are seeking a Process Engineer III to provide drug delivery device production innovation support. This role focuses on industrializing combination drug delivery devices for parenteral pharmaceutical therapeutics. The ideal candidate will have extensive experience in high-volume manufacturing processes and methodologies, supporting both clinical and commercial production activities. The role involves engaging with internal partners and external manufacturing partners and component suppliers.

Key Responsibilities:

Process Engineering:

  • Provide DFM/DFA assessments of container-device and develop testing methods to assess container and delivery system quality and functionality.
  • Lead process development using state-of-the-art technology for clinical and commercial production.
  • Apply tools such as tolerance analysis, DOE, design for reliability, and Six Sigma methodologies.
  • Characterize critical process parameters (CPPs) and material attributes (MAs) using appropriate tools and simulations.
  • Lead evaluations and investigations using root cause analysis tools.
  • Procure and design lab-scale clinical manufacturing equipment and fixtures.
  • Author and review documentation related to equipment qualification and process validation.
  • Provide engineering technical leadership to internal teams and external partners.

Quality System Compliance:

  • Implement and maintain client Pharma Quality Policy and Pharma Quality System (PQS).
  • Conduct Root Cause Analysis on manufacturing defects and collaborate on Engineering Change Requests (ECR), Material Review Board (MRB), and Corrective and Preventive Action (CAPA).
  • Ensure compliance with local procedures and templates, aligning with PQS documents and best practices.
  • Assist in resolving issues from quality assessments, regulatory inspections, and notified body interactions.

Design Controls:

  • Oversee the transfer of design to commercialization.
  • Ensure product quality and design requirements are met through the equipment development, process development, and validation process.
  • Draft, review, and approve design control documents to support device development deliverables.
  • Maintain good document practices (GDP) for recording data, archiving, and drafting/reviewing documents.
  • Participate in hazard analysis and design assessments.

Interfaces and Collaboration:

  • Interface with leaders in Contract Manufacturing, Procurement, Quality, Complaints, and Regulatory Affairs.
  • Collaborate with design engineers, equipment, and production engineers.
  • Support supplier selection and assessment for existing equipment and custom automation development.

Qualifications:

Education and Experience:

  • B.S., M.S., or advanced degree in Engineering, preferably Mechanical Engineering.
  • At least 3 years of experience in the industry or academia post-Bachelors degree.
  • Extensive experience in high-volume manufacturing processes, particularly in plastic molding and mechanical assembly.
  • Proven success in liaising with engineering and manufacturing resources.
  • Experience with control systems for production and batch release.

Technical Knowledge:

  • At least 3 years supporting process development from feasibility to New Product Introduction.
  • Knowledge of regulatory compliance and design controls (ISO 13485, GDP/GLP/GMP).
  • Experience with assembly equipment, functional testers, and various testing systems.
  • Strong skills in data and statistical analysis tools (JMP, Minitab) and design methodologies.
  • Six Sigma certification (Green/Black Belt) is preferred.

Interpersonal Skills:

  • Effective in a matrix organization and cross-functional collaboration.
  • Excellent oral and written communication skills.
  • Ability to work with external design/development and production partners.
  • Highly organized and detail oriented.

Training Requirements:

  • Completion of core training within the allotted time frame starting from the onboard date.